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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04352634




Registration number
NCT04352634
Ethics application status
Date submitted
8/04/2020
Date registered
20/04/2020
Date last updated
1/04/2021

Titles & IDs
Public title
The Covid-19 HEalth caRe wOrkErS (HEROES) Study
Scientific title
The Impact of the Covid-19 Pandemic on the Mental Health of Workers in Health Services: The Covid-19 HEalth caRe wOrkErS (HEROES) Study
Secondary ID [1] 0 0
HEROES Covid-19
Universal Trial Number (UTN)
Trial acronym
HEROES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Covid-19 0 0
Mental Health Disorder 0 0
Stress Disorder 0 0
Anxiety 0 0
Depression 0 0
SARS-CoV-2 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Exposure to the SARS-CoV-2 and its consequences

Healthcare workers - Workers who interact with people with confirmed or suspected COVID-19 at different health services (primary care centers, emergency units, specialized care units, inpatient care units, critically ill patient units, among others). Potential participants will include any type of worker in these centers, including clinical and administrative staff, as well as supportive staff (e.g., food services)


Other interventions: Exposure to the SARS-CoV-2 and its consequences
This is an observational design. Participants are exposed to the SARS-CoV-2, the Covid-19 pandemic, and/or its consequences
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Anxiety and depressive symptoms
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Experiences, fears and concerns about the Covid-19
Timepoint [1] 0 0
Baseline
Secondary outcome [2] 0 0
Experiences, fears and concerns about the Covid-19
Timepoint [2] 0 0
3 months
Secondary outcome [3] 0 0
Experiences, fears and concerns about the Covid-19
Timepoint [3] 0 0
6 months
Secondary outcome [4] 0 0
Experiences, fears and concerns about the Covid-19
Timepoint [4] 0 0
12 months
Secondary outcome [5] 0 0
Training and resource prioritization
Timepoint [5] 0 0
Baseline
Secondary outcome [6] 0 0
Training and resource prioritization
Timepoint [6] 0 0
3 months
Secondary outcome [7] 0 0
Training and resource prioritization
Timepoint [7] 0 0
6 months
Secondary outcome [8] 0 0
Training and resource prioritization
Timepoint [8] 0 0
12 months
Secondary outcome [9] 0 0
Suicide ideation (presence)
Timepoint [9] 0 0
Baseline
Secondary outcome [10] 0 0
Suicide ideation (presence)
Timepoint [10] 0 0
3 months
Secondary outcome [11] 0 0
Suicide ideation (presence)
Timepoint [11] 0 0
6 months
Secondary outcome [12] 0 0
Suicide ideation (presence)
Timepoint [12] 0 0
12 months
Secondary outcome [13] 0 0
Suicide ideation (frequency)
Timepoint [13] 0 0
Baseline
Secondary outcome [14] 0 0
Suicide ideation (frequency)
Timepoint [14] 0 0
3 months
Secondary outcome [15] 0 0
Suicide ideation (frequency)
Timepoint [15] 0 0
6 months
Secondary outcome [16] 0 0
Suicide ideation (frequency)
Timepoint [16] 0 0
12 months
Secondary outcome [17] 0 0
Acute stress symptoms
Timepoint [17] 0 0
Baseline
Secondary outcome [18] 0 0
Acute stress symptoms
Timepoint [18] 0 0
3 months
Secondary outcome [19] 0 0
Acute stress symptoms
Timepoint [19] 0 0
6 months
Secondary outcome [20] 0 0
Acute stress symptoms
Timepoint [20] 0 0
12 months
Secondary outcome [21] 0 0
Psycho/social support and network
Timepoint [21] 0 0
Baseline
Secondary outcome [22] 0 0
Psycho/social support and network
Timepoint [22] 0 0
3 months
Secondary outcome [23] 0 0
Psycho/social support and network
Timepoint [23] 0 0
6 months
Secondary outcome [24] 0 0
Psycho/social support and network
Timepoint [24] 0 0
12 months
Secondary outcome [25] 0 0
Resilience
Timepoint [25] 0 0
Baseline
Secondary outcome [26] 0 0
Resilience
Timepoint [26] 0 0
3 months
Secondary outcome [27] 0 0
Resilience
Timepoint [27] 0 0
6 months
Secondary outcome [28] 0 0
Resilience
Timepoint [28] 0 0
12 months
Secondary outcome [29] 0 0
Anxiety and depressive symptoms
Timepoint [29] 0 0
Baseline
Secondary outcome [30] 0 0
Anxiety and depressive symptoms
Timepoint [30] 0 0
3 months
Secondary outcome [31] 0 0
Anxiety and depressive symptoms
Timepoint [31] 0 0
6 months

Eligibility
Key inclusion criteria
* Legal age
* Currently working on a health service that provides care to COVID-19 patients
* Give informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Inability to use electronic devices (required to complete the survey)

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/04/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
2000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
University of Sydney - Sidney
Recruitment postcode(s) [1] 0 0
2031 - Sidney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
Argentina
State/province [2] 0 0
Chubut
Country [3] 0 0
Armenia
State/province [3] 0 0
Yerevan
Country [4] 0 0
Bolivia
State/province [4] 0 0
Chuquisaca
Country [5] 0 0
Chile
State/province [5] 0 0
Santiago
Country [6] 0 0
Costa Rica
State/province [6] 0 0
Heredia
Country [7] 0 0
Czechia
State/province [7] 0 0
Bohemia
Country [8] 0 0
Germany
State/province [8] 0 0
Niedersachsen
Country [9] 0 0
Guatemala
State/province [9] 0 0
Guatemala City
Country [10] 0 0
Italy
State/province [10] 0 0
CA
Country [11] 0 0
Italy
State/province [11] 0 0
Cagliari
Country [12] 0 0
Lebanon
State/province [12] 0 0
Beirut
Country [13] 0 0
Mexico
State/province [13] 0 0
Jalisco
Country [14] 0 0
Netherlands
State/province [14] 0 0
Limburg
Country [15] 0 0
Nigeria
State/province [15] 0 0
Oyo State
Country [16] 0 0
Puerto Rico
State/province [16] 0 0
Ponce
Country [17] 0 0
Saudi Arabia
State/province [17] 0 0
Central
Country [18] 0 0
Spain
State/province [18] 0 0
Madrid
Country [19] 0 0
Tunisia
State/province [19] 0 0
La Manouba
Country [20] 0 0
Turkey
State/province [20] 0 0
Sariyer
Country [21] 0 0
Venezuela
State/province [21] 0 0
Aragua

Funding & Sponsors
Primary sponsor type
Other
Name
University of Chile
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Columbia University
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Since December 2019 the world has been shaken with an enormous global threat: the Covid-19 pandemic. This new kind of coronavirus is generating an unprecedented impact both on the general population and on the healthcare systems in most countries. Health services are trying to expand their capacity to respond to the pandemic, taking actions such as increasing the number of beds; acquiring necessary equipment to provide intensive therapy (ventilators), and calling retired health professionals and health students so they can assist the overwhelmed health care workforce. Unfortunately, these organizational changes at health facilities, along with the fears and concerns of becoming ill with the virus or infecting their families, put an enormous emotional burden on workers in health services which may lead to negative outcomes on mental health in this population.

Recent cross-sectional studies in China indicate that health service workers exposed to people with Covid-19 reported higher rates of depressive and anxious symptoms. This negative impact on mental health among health workers in China has also been informally reported in other countries where the Covid-19 pandemic has been devastating in its effects (such as Spain and Italy), as well as in countries where the pandemic is becoming a growing public health problem. This is particularly relevant in regions with fewer resources (Latin America, North Africa), where there are limited means and the response from the health system is usually insufficient. Moreover, it is necessary to study these negative effects longitudinally considering that some effects will appear over time (post-traumatic stress).

The COVID-19 HEalth caRe wOrkErS (HEROES) study is a large, bottom-up, South-North initiative aimed to evaluate the impact of the COVID-19 pandemic on the mental health of health care workers (HCWs). HEROES encompasses a wide variety of academic institutions in 19 LMICs and 8 HICs, in partnership with the Pan American Health Organization (PAHO) and with support from the World Health Organization (WHO). The HEROES study is led by Dr. Rubén Alvarado at University of Chile, and Dr. Ezra Susser and Franco Mascayano at Columbia U Mailman School of Public Health.
Trial website
https://clinicaltrials.gov/study/NCT04352634
Trial related presentations / publications
Brooks SK, Webster RK, Smith LE, Woodland L, Wessely S, Greenberg N, Rubin GJ. The psychological impact of quarantine and how to reduce it: rapid review of the evidence. Lancet. 2020 Mar 14;395(10227):912-920. doi: 10.1016/S0140-6736(20)30460-8. Epub 2020 Feb 26.
Nacoti M, et al. At the Epicenter of the Covid-19 Pandemic and Humanitarian Crises in Italy: Changing Perspectives on Preparation and Mitigation. NEJM Catalyst, 2020;1(2)
Huang L, Lei W, Xu F, Liu H, Yu L. Emotional responses and coping strategies in nurses and nursing students during Covid-19 outbreak: A comparative study. PLoS One. 2020 Aug 7;15(8):e0237303. doi: 10.1371/journal.pone.0237303. eCollection 2020.
Lai J, Ma S, Wang Y, Cai Z, Hu J, Wei N, Wu J, Du H, Chen T, Li R, Tan H, Kang L, Yao L, Huang M, Wang H, Wang G, Liu Z, Hu S. Factors Associated With Mental Health Outcomes Among Health Care Workers Exposed to Coronavirus Disease 2019. JAMA Netw Open. 2020 Mar 2;3(3):e203976. doi: 10.1001/jamanetworkopen.2020.3976.
Public notes

Contacts
Principal investigator
Name 0 0
Rubén Alvarado, PhD
Address 0 0
University of Chile [Universidad de Chile]
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Rubén Alvarado, PhD
Address 0 0
Country 0 0
Phone 0 0
+56 2 2978 6967
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04352634